Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to provide an effective repetitive transcranial magnetic stimulation (rTMS) treatment for depressive symptoms in patients with schizophrenia. Schizophrenia patients with depressive symptoms will be exposed to rTMS to improve their symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female ages between ages 18-60 years.

Ability to give written informed consent (age 18 or above).

Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.

Score of Calgary depression scale for schizophrenia (CDSS) ≥ 3.

Disqualifiers

Inability to sign informed consent.

Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but are not limited to: stroke, repeated seizure, history of significant head trauma with cognitive sequela, CNS infection or tumor, other significant brain neurological conditions.

Significant alcohol or other drug use other than nicotine or marijuana dependence.

Inability to refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active rTMS stimulation

    Device

    Active H-coil delivered rTMS sessions will be given three times per treatment visit for up to 20 visits for about 4 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.

  • Sham rTMS stimulation

    Device

    Sham H-coil delivered rTMS sessions will be given three times per treatment visit for up to 20 visits for about 4 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Active rTMS stimulationActive comparator 1 intervention
Group B: Sham rTMS stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI)

rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity.

Time frame
baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline)

Secondary outcomes

1

Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)

Mismatch negativity values will be reported in microvolts (uV). Mismatch negativity is measured by subtracting the averaged response to a set of standard stimuli from the average response to deviant stimuli, and taking the amplitude of this difference in a given timepoint.

Time frame
baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline)
2

Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG)

Steady-state auditory evoked responses will be reported. The responses are measured by calculating the ratio of the power at target frequency over power at the surrounding background frequencies. The ration will be obtained in a given timepoint.

Time frame
baseline, visit 11 (about 2 week after baseline), visit 21 (about 4 weeks after baseline)
3

Depression as assessed by the Calgary Depression Scale

Total score of the Calgary Depression Scale will be reported and ranges from 0 to 27, with a higher score indicating greater depression.

Time frame
baseline, visit 11 (about 2 week after baseline), visit 21(about 4 weeks after baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator